📋 FDA Reference
Permanent Myocardial Leads Mp Series
Oscor Medical
Summary: The Permanent Myocardial Leads MP Series by Oscor Medical are used for cardiac pacing in patients requiring permanent pacemaker implantation. They are typically utilized by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K872971 ↗
Decision Date ?
February 12, 1988
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Permanent Myocardial Leads MP Series received FDA clearance through the 510(k) pathway on February 12, 1988. Manufactured by Oscor Medical, this Class III device is used in cardiac applications.
What It Is
The Permanent Myocardial Leads MP Series are specialized leads designed for permanent implantation in the myocardium to facilitate cardiac pacing. These leads are essential components of pacemaker systems, providing electrical stimulation to maintain adequate heart rhythm. They are typically inserted via a transvenous approach and secured within the heart muscle to ensure reliable pacing.
FDA-Cleared Indications
- Use in patients who require permanent cardiac pacing.
- Use to provide electrical stimulation of the myocardium as part of a permanent pacemaker system.
Clinical Applications
- Permanent pacemaker implantation for patients requiring long-term pacing support.
- Cardiac pacing in patients with bradycardia when permanent pacing is clinically indicated.
- Cardiac pacing in patients with heart block or other conduction disorders requiring permanent pacing.
- Placement and connection of a myocardial pacing lead to a compatible pacemaker generator.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator and connector system.
- Clinicians should select an appropriate lead length and configuration for the patient's anatomy and implantation approach.
- Secure myocardial fixation and careful lead handling are important to reduce dislodgement, insulation damage, and loss of pacing function.
- MRI safety cannot be determined from this historical FDA record alone; the lead, generator, and complete implanted system should be evaluated against current MRI-conditional labeling.
- Contraindications, precautions, and implantation technique should be confirmed in the manufacturer's current instructions for use and the applicable pacemaker system labeling.
Frequently Asked Questions
What is Permanent Myocardial Leads MP Series used for?
These leads are used for permanent cardiac pacing in patients with conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads in hospital settings.
What are the FDA-cleared indications?
The leads are indicated for patients requiring permanent pacing due to bradycardia or heart block.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.